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The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to estimate the incidence of perianal MBL-CRE colonization, the proportion of subsequent infections, the associated risk factors, mortality, and the underlying antibiotic resistance mechanisms.
The main questions this study seeks to answer are:
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perianal MBL-CRE colonization. | The proportion of patients who develop perianal colonization with metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) following allogeneic hematopoietic stem cell transplantation (HSCT). | Within 100 days after allogeneic HSCT. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MBL-CRE Infection Among Colonized Patients. | The proportion of patients with documented perianal MBL-CRE colonization who subsequently develop MBL-CRE clinical infection. | From the time of colonization to 6 months after HSCT. |
| Infection-Related Mortality. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation.
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Biospecimens (perianal swab isolates of CRE) will be retained. DNA will be extracted from MBL-CRE isolates for whole-genome sequencing.
The proportion of patients with MBL-CRE infection who die due to infection-related causes within 28 days after onset of infection. |
| 28 days after documented onset of MBL-CRE infection. |
| All-Cause Mortality. | The proportion of patients with MBL-CRE infection who die from any cause within 28 days after infection onset. | 28 days after documented onset of MBL-CRE infection. |
| Clinical Cure Rate | The proportion of MBL-CRE-infected patients who achieve complete clinical resolution of infection-related signs and symptoms after treatment. | 28 days (range: 25-31 days) after initiation of antimicrobial therapy |
| Microbiological Eradication Rate. | The proportion of infected patients with documented clearance of MBL-CRE from repeat culture specimens after treatment. | 14 days (range: 11-17 days) and 28 days (range: 25-31 days) after initiation of antimicrobial therapy. |
| Risk Factors for MBL-CRE Colonization and Infection | Identification of clinical, demographic, and treatment-related variables associated with perianal MBL-CRE colonization and subsequent infection. | From transplantation to 6 months post-transplant. |